Effect of Acupuncture on Patient Vulvodynia Outcomes

Brief Title

Effect of Acupuncture on Patient Vulvodynia Outcomes

Official Title

Double-blind Phase 2 RCT: Effect of Acupuncture on Patient Vulvodynia Outcomes

Brief Summary

      This study evaluates acupuncture for the treatment of vulvodynia; specifically if it reduces
      vulvar pain and pain with intercourse. It also examines how long the effect of acupuncture
      lasts in women with vulvodynia. Half of the women will receive acupuncture and the other half
      will receive placebo acupuncture. Women who get a reduction in pain will monitor there pain
      once a week for up to 12 weeks to see how long the acupuncture effect lasts.
    

Detailed Description

      The investigators' goal is to demonstrate the effects of acupuncture for the treatment of
      vulvodynia. Up to 14 million American women have vulvodynia, a debilitating pain syndrome
      characterized by pain (burning, irritation, stinging or rawness) in the vulva and dyspareunia
      that renders sexual intercourse virtually impossible and leaves these women desperate for
      relief. Not only are women in pain, but they often lose their partners or have relationship
      difficulties due to their inability to have sexual intercourse. No therapies have been proven
      efficacious and rapid pain relief is unpredictable and rarely possible. After exhausting
      Western Medicine options, these women often turn to acupuncture. But in contrast to other
      pain conditions, there have been no acupuncture sham control studies of vulvodynia.

      Only four studies, including one of the investigators', provide some evidence of the effect
      of acupuncture on vulvodynia. In three, single-group acupuncture studies, women had less
      pain, better quality of life, improved sexual health, and improved mental health. The
      investigators' randomized wait-list controlled pilot study of 36 women with vulvodynia showed
      great promise. The investigators found a statistically significant and clinically meaningful
      reduction in vulvar pain and dyspareunia, and an increase in overall sexual function after a
      5-week, 13-needle, 10 session acupuncture protocol. This newly developed, standardized
      acupuncture treatment protocol is the first breakthrough in the treatment of this puzzling
      disorder. It includes acupuncture points that relieve pain in the genitals. The results of
      the investigators' initial pilot study provided the first evidence from a two-group design
      that the acupuncture protocol could reduce pain intensity, pain during intercourse, and
      increase overall sexual function. These findings, however, warrant stronger evidence to
      support the inference that the effect is indeed due to the acupuncture since ours or no other
      study included a sham control or provided follow-up data beyond immediate posttest, which
      means that the duration of the acupuncture effect is unknown. The investigators' recent
      feasibility study paves the way to overcome this gap by use of double-blind acupuncture
      needles. Findings from these two studies support the investigators' proposal for the world's
      first double-blind randomized controlled trial (RCT) of acupuncture for vulvodynia while
      exploring its duration of effect.

      The investigators propose a phase 2 double-blind, pretest/posttest RCT to compare effects of
      penetrating needles or the skin touch placebo needles on vulvar pain in our 13-needle,
      10-session acupuncture treatment protocol. A sample of 130 women, with a diagnosis of
      vulvodynia, either generalized or provoked vestibulodynia, 18 to 45 years of age will be
      recruited from clinical and community settings and 80 subjects are expected to complete the
      study. Stratified by type of vulvodynia, participants will be randomized 1:1 either to the
      penetrating needle group or the skin touch placebo needle group. These double-blind needles
      will provide a strong sham procedure to mask both the acupuncturist and subject to the type
      of needle used for the 10-treatment protocol.

      Specific aims are to:

      Aim 1. Compare the penetrating needle group and the skin touch placebo needle group for
      effects on the: (a) primary outcome: vulvar pain (PAINReportIt® average pain intensity,
      0-10), and (b) secondary outcomes: dyspareunia (FSFI dyspareunia) and sexual function (FSFI
      total). The investigators hypothesize that controlling for baseline values, at posttest there
      will be statistically significant less vulvar pain (primary) and dyspareunia and better
      sexual function in the penetrating needle group compared to the skin touch placebo group.

      Aim 2. In participants with a clinically meaningful reduction in pain intensity (at least 1.5
      points) at posttest compared to pretest, describe the duration of the acupuncture treatment
      and placebo effects weekly until pain returns to pretest or up to 12 weeks after posttest.
      The investigators will describe the variability over time in vulvar pain intensity (0-10)
      after a tampon insertion-removal stimulus and thereby explore the duration of the effect by
      intervention group, vulvodynia subgroups, and demographic subgroups (e.g., age, race,
      occupation). These findings will provide insights to guide future research on initial and
      maintenance acupuncture for vulvodynia.
    


Study Type

Interventional


Primary Outcome

Average Pain Intensity will be measured with the Pain Intensity Numbers Scale (PINS).

Secondary Outcome

 Dyspareunia Subscale of the Female Sexual Function Index (FSFI)

Condition

Vulvodynia

Intervention

Active Acupuncture

Study Arms / Comparison Groups

 Experimental: Active Acupuncture
Description:  Active Acupuncture two times per week for 5 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

80

Start Date

April 15, 2018

Completion Date

September 2022

Primary Completion Date

September 2022

Eligibility Criteria

        Inclusion Criteria:

          1. a previous diagnosis of generalized vulvodynia or provoked vestibulodynia

          2. 18 to 45 years old

          3. a pain now score 4 or higher with tampon insertion and removal performed at the
             initial screening exam

          4. speak and read English

        Exclusionary Criteria:

          1. infectious conditions of the vulva/vagina

          2. inflammatory conditions of the vulva/vagina

          3. neoplastic disorders of the vulva/vagina

          4. neurologic disorders of the vulva/vagina

          5. trauma to the genitals

          6. iatrogenic conditions of the genitals

          7. hormonal deficiencies

          8. co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic
             inflammatory disease and documented history of endometriosis

          9. menopause

        Patients may have a history of but not have active in the last 6 months migraine headaches,
        temporomandibular joint disease (TMJ), irritable bowel syndrome (IBS), interstitial
        cystitis, painful bladder syndrome, or fibromyalgia.

        -
      

Gender

Female

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Judith M. Schlaeger, PhD, (312) 413-5449, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03364127

Organization ID

2017-0885


Responsible Party

Principal Investigator

Study Sponsor

University of Illinois at Chicago

Collaborators

 University of Florida

Study Sponsor

Judith M. Schlaeger, PhD, Principal Investigator, University of Illinois at Chicago


Verification Date

August 2020